NCT07182591 A Study of DS5361b in Participants With Advanced Solid Tumors
| NCT ID | NCT07182591 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Daiichi Sankyo |
| Condition | Advanced Solid Tumor |
| Study Type | INTERVENTIONAL |
| Enrollment | 192 participants |
| Start Date | 2025-10-02 |
| Primary Completion | 2030-03-18 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
This study aims to assess the safety, tolerability, and preliminary efficacy and to determine the MTD of DS5361b in monotherapy and combination with pembrolizumab in participants with advanced or metastatic solid tumors.
Eligibility Criteria
Key Inclusion Criteria: The clinical site will screen for the full inclusion criteria per protocol. 1. Adults ≥18 years of age at the time the ICF is signed (Please follow local regulatory requirements if the legal age of consent for trial participation is \>18 years old). 2. Has histologically- or cytologically documented recurrent, metastatic, or unresectable solid tumors that are refractory to or intolerable with standard treatment or for which no standard treatment is available (For Part 1 and Part 2 only). 3. Participants need to have documented TMB or MSI status using a validated or approved genomic test as per applicable regulations prior to Cycle 1 Day 1. In Part 1 and Part 2, participants need to have documented TMB-H and/or MSI-H status. In Part 3, participants need to have documented TMB-H status. 4. Has measurable disease based on local CT/MRI imaging as assessment by the investigator using RECIST v1.1. 5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.